Allogeneic Stem Cell Transplantation for Myelofibrosis and Myelodysplastic Syndrome

• Status: Completed
• Trial end date: 2017-10-04
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this clinical research study is to learn if using a combination of fludarabine, busulfan, and antithymocyte globulin (ATG) can help to control myelofibrosis or myelodysplastic syndrome in patients receiving a bone marrow or blood stem cell transplant. The safety of these drugs will also be studied.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Antilymphocyte Serum; Busulfan; Fludarabine; Fludarabine phosphate; Thymoglobulin; Vidarabine

Criteria

Inclusion Criteria:

1. Patients with Idiopathic Myelofibrosis or Myelofibrosis secondary to Polycythemia Vera or Essential Thrombocythemia or Myelodysplastic syndrome with or without fibrosis.

2. Patients 75 years or younger

3. Patients must have an HLA matched or at least a 9/10 antigen (A, B, C, DQ or DR) matched related or unrelated donor.

4. Patients must have a Zubrod PS 2 or less.

5. Creatinine < 1.6 mg/dl

6. Ejection fraction >/= 40%, unless cleared by cardiology

7. Serum direct bilirubin < 2 mg/dl (unless due to Gilbert's syndrome), serum glutamate pyruvate transaminase (SGPT)

8. Forced expiratory volume at one second (FEV1), forced vital capacity (FVC), or diffusing capacity of lung for carbon monoxide (DLCO) >/= 40% of expected.

9. Negative Beta human chorionic gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.

Exclusion Criteria:

1. Uncontrolled life-threatening infections

2. HIV positive

3. Patients with Active viral hepatitis